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To evaluate the blood pressure lowering effects of the combination of aliskiren 300 mg and HCTZ 25 mg in obese patients with essential hypertension inadequately treated with HCTZ 25 mg, compared to irbesartan or amlodipine with HCTZ or HCTZ alone.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aliskiren | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in mean sitting diastolic blood pressure after 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in mean sitting systolic blood pressure after 8 weeks | ||
| Evaluate number mean sitting systolic/diastolic response from baseline to weeks 4 and 8 | ||
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Inclusion Criteria
Exclusion Criteria
Other protocol-defined inclusion exclusion criteria also apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Pharmaceuticals | East Hanover | New Jersey | 07936 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17353513 | Result | Jordan J, Engeli S, Boye SW, Le Breton S, Keefe DL. Direct Renin inhibition with aliskiren in obese patients with arterial hypertension. Hypertension. 2007 May;49(5):1047-55. doi: 10.1161/HYPERTENSIONAHA.106.084301. Epub 2007 Mar 12. |
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| Mean sitting diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after week 8 |
| Achieve mean sitting blood pressure control target of < 140/90 mmHg after week 8 |
| Investigative Centers |
| Germany |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C446481 | aliskiren |
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